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Incidence of Simultaneous Epidural and Intravascular Injection

NCT01020929 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2012-06-06

No results posted yet for this study

Summary

The investigator hopes to learn the incidence of needle placement in both the epidural and intravascular space, and learn mixed epidural-intravascular pattern related to needle type, gauge, and level of injection. We also hope to evaluate the length of fluoroscopy time when using real time fluoroscopy during contrast dye injection, evaluate the radiation exposure to the hands of the physician during this protocol, and confirm the incidence fo intravascular injection and sensitivity of needle flash of blood, In the lumbar spine, vascular contrast patterns are more than twice as likely to appear simultaneous to the anticipated epidural pattern, than they are to occur alone. This is important since practitioners are more likely to miss a vascular pattern that occurs simultaneous to epidural spread, than they are to occur alone. The incidence of intravascular penetration in cervical transforaminal epidural injections is known to exceed that of lumbar injections, however no study has determined the incidence of simultaneous epidural and vascular injection in the cervical spine. This study may prove that real time fluoroscopy during contrast injection is warranted to prevent intravascular injection and resultant side effects to support this as standard of care.

Intermittent fluoroscopy can yield false-negative results for intravascular injection when simultaneous epidural and intravascular injection occurs. This could lead to an increased risk of complication from intravascular injection of medications and reduce overall efficacy. No studies to date have quantified the incidence of needle placement located in both the intravascular space and epidural space simultaneously.

Conditions

  • Spinal Diseases

Interventions

DEVICE

Blunt Coude

Type of needle tip

DEVICE

Quincke

Type of needle tip

DEVICE

Trucath

Type of needle tip

Sponsors & Collaborators

Principal Investigators

  • Matthew W Smuck · Stanford University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-08-31
Completion
2011-09-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01020929 on ClinicalTrials.gov